Graseby 3300 PCA Pump Instruction Manual Aug 2002

Graseby 3300 PCA Pump

Instruction Manual

Published by Graseby Medical Limited. All possible care has been taken in the preparation of this publication, but Graseby Medical Limited does not accepts any liability for any inaccuracies that may be found. Graseby Medical reserves the right to make changes without notice both to this publication and to the product which it describes. Graseby Medical seeks constantly to improve their products, therefore, the specification for the 3300 pump is subject to change. Copyright © 2002 Graseby Medical Limited. No part of this publication may be reproduced, transmitted, transcribed, or stored in a retrieval system or translated into any human or computer language in any form or by any means without the prior permission of Graseby Medical Limited. GRASEBY MEDICAL LIMITED, Colonial Way, Watford, Hertfordshire, United Kingdom, WD24 4LG TELEPHONE: FAX: INTERNET:

(+44) (0)1923 246434 (+44) (0)1923 231595 www.graseby.co.uk

REGISTERED IN ENGLAND. COMPANY NO. 995550 Trademarks and acknowledgements: “Graseby” “Smiths” and “Flo-Safer” are all registered trademarks of the Smiths Group plc. All other trademarks are acknowledged as the property of their respective owners.

PCA Pump For the attention of users of 3300s with version 4.2 software (the previous version). New Features •

The PUMP NOT RUNNING warning previously had additional text.

•

SYRINGE EMPTY now reads SYRINGE EMPTY/OCCLUSION

•

The occlusion alarm displays have RELEASE PLUNGER CLAMP added and are shown for a longer period.

•

The dose limit exceeded alarm display is shown for a longer period. For additional safety, it is now reset by opening the cover and pressing the down key as per the instructions on the screen.

•

The external monitor alarm display is shown for a longer period. For additional safety, it is now reset by opening the cover and pressing the down key as per the instruction on the screen.

These software improvements should not present any problem to users of earlier software versions even if this 3300 is used alongside 3300s at a previous release of software. Should you feel a need to upgrade all of your pumps to the current version of software, please contact Graseby Medical or your local distributor.

Graseby 3300

i

PCA Pump

Warnings

Warnings tell you about dangerous conditions that could lead to death or serious injury to the user or patient that can occur if you do not obey all of the instructions in this manual. 1. WARNING: To avoid over- or under- infusion, always verify that the brand and size of the loaded syringe are the same as the brand and size displayed on the screen before starting an infusion. Failure to do so may result in an inaccurate delivery of medication, resulting in patient injury or death. 2. WARNING: To avoid incorrect or inappropriate configuration of the pump, the Configuration menu must only be selected by qualified persons or authorised personnel. Incorrect pump configuration could lead to inappropriate infusion resulting in patient injury or death. 3. WARNING: This equipment is not suitable for use in the presence of flammable anaesthetics, oxygen-enriched or explosive atmospheres. The use of the device in such atmospheres may lead to explosion or fire. 4. WARNING: To avoid possible malfunction of the pump, do not expose the pump to X- rays, gamma rays or ionizing radiation, or to the RF interference or strong electric/magnetic fields emitted (for example) by diathermy equipment or mobile telephones. If the pump is used in the presence of, or in combination with Magnetic Resonance Imaging (MRI) machines it must be protected from the magnetic field emitted by such equipment. Malfunction of the pump can cause incorrect infusion or loss of infusion resulting in patient injury or death. 5. WARNING: Operation of the pump outside the temperature limits defined in the specification may result in erroneous operation. Ensure that the temperature is within the specified limits. Failure to do so may result in patient injury or user injury. 6. WARNING: In order to ensure that the intended infusion is performed, data must be entered correctly. Likewise before confirming any displayed data the user should ensure that it is correct. Failure to do so may result in compromised function of the product, patient injury or user injury. 7. WARNING: Failure to respond promptly to an alarm may result in patient injury or death. 8. WARNING: Failure to follow the Service Manual’s maintenance schedule recommendations may result in compromised function of the product and lead to patient injury or death. 9. WARNING: It is essential that clinical staff remain within visual and audible range of the pump so that critical alarms can be seen or heard and responded to. 10. WARNING: The user should ensure that the performance offered by the pump is fit for the intended purpose. Failure to do so may result in compromised function of the product, patient injury or user injury. 11. WARNING: When the pump is carrying out an infusion, to ensure that electrical safety is maintained only items of equipment that conform to EN60950 are to be connected to the RS232 connector situated at the base of the pump, otherwise patient safety may be compromised. 12. WARNING: Correct management of battery charging is essential to ensure that the pump can operate on batteries for the time specified. Failure to do so may lead to impaired functioning of the pump, resulting in patient injury or death.

ii

Graseby 3300

PCA Pump 13. WARNING: Do not use a faulty pump. If the pump develops a fault then an alarm will sound; the display will indicate a FAULT condition and the pump will fail to infuse. Incorrect performance of the pump can cause complications resulting in patient injury or death. If the pump develops a fault then it must be referred to a suitably qualified engineer or returned to Graseby Medical in order to have the fault rectified. 14. WARNING: Failure to use the mains lead clamp means that the pump may be accidentally or erroneously disconnected from the mains. Although there is battery backup in case this happens, the battery may not be sufficiently charged. Consequently there is a risk of the pump not functioning, which could lead to patient injury or death. 15. WARNING: If an occlusion alarm occurs, immediately clamp the line to eliminate the possibility of a bolus being delivered to the patient. Then inspect the fluid pathway for kinks, clogged catheter, etc. in order to remove the occlusion prior to restarting the infusion. An unintentional bolus of medication can result in patient injury or death. 16. WARNING: Use only the syringes and administration sets listed in the Specification at the end of this manual. Failure to do so may result in an inaccurate delivery. Graseby Medical does not guarantee performance of the pump if syringes other than those listed are used. Incorrect function or performance of the pump can cause complications resulting in patient injury or death. 17. WARNING: The volume of fluid contained in the connecting tubing is a residual amount and will not be infused. Hence this extra volume of fluid must be allowed for when initially filling the syringe and purging the system. Under-delivery of medication can cause complications resulting in patient injury or death. 18. WARNING: To avoid patient embolism, ensure that the patient tubing is purged of all air bubbles before administering any medication. The pump provides a purge facility to assist with this process. The presence of air within the medication can result in complications leading to patient injury or death. 19. WARNING: To avoid syphoning of the syringe contents (free flow), ensure that the syringe is correctly loaded into the pump, that the syringe plunger is properly engaged by the pump’s actuator and that the pump is placed not more than 80cm above the infusion site. Syphoning can result in over-infusion leading to patient injury or death. 20. WARNING: To avoid over-infusion, do not purge the infusion line when the administration set is connected to the patient. Over-infusion of medication can result in patient injury or death. 21. WARNING: To avoid the pump becoming detached from an IV pole always make sure that the pump is securely fixed to the pole. Always check the security and stability of the assembly with the pump mounted. If no IV pole is used make sure that the pump is completely stable on a horizontal surface. Failure to observe this warning may cause damage to the 3300 PCA pump and harm the operator or the patient. As a result, the operator or patient may suffer direct injury, or the 3300 PCA pump may fail to operate correctly, leading to patient injury or death. 22. WARNING: Following a significant liquid spill onto the pump, it should be wiped dry and inspected by service personnel before being returned to service. Failure to do so may result in compromised functioning of the pump, leading to patient or user injury or death.

Graseby 3300

iii

PCA Pump 23. WARNING: When using a syringe smaller than 50/60 ml the occlusion pressure will increase as the diameter of the syringe decreases, i.e. the smaller the syringe the higher the pressure 24. WARNING: The patient history is lost when the clock is reset.

Cautions

Cautions tell you about dangerous conditions that can occur and cause damage to the pump if you do not obey all of the instructions in this manual. 1. CAUTION: Refer all service, repair and calibrations only to qualified technical personnel. Unauthorised modifications to the pump must not be carried out. 2. CAUTION: When turning the pump on if screens similar to those illustrated are not displayed, do not use the pump. Send the pump to a suitably qualified engineer or return it to Graseby Medical in order to have the fault rectified. 3. CAUTION: Do not use cleaning and disinfecting agents other than the approved ones specified here. 4. CAUTION: The pump must not be immersed in any liquids or exposed to strong organic solvents. Wipe off spills immediately, and do not allow fluid or residues to remain on the pump. Additionally, the pump is not designed to be autoclaved, steam-sterilised, ETO-sterilised or subjected to temperatures in excess of 45° C (113° F). Failure to observe this caution may cause serious damage to the pump. 5. CAUTION: If the pump is used in close proximity to a fluid bag(s), it should where possible, not be mounted directly underneath the fluid bag(s). This is to minimise the possible risk of damage to the pump from fluid ingress should the bag rupture or leak during use.

U.S.A. and Canada

Federal law in the U.S.A. and Canada restricts this device to sale by or on the order of a licensed Medical Practioner.

FOR THE ATTENTION OF USA USERS

Application Information required by FDA. for Epidural Applications please note: 1. The device can be used for analgesic infusion. 2. Infusion may be short-term (up to 96 hrs), or long-term in accordance with the catheter and drug labelling. 3. Use only catheters indicated for epidural administration. 4. Infusion sets with Y-connection sites should not be used for epidural applications. 5. The device must be used to administer only those analgesics which are approved for epidural administration as indicated by the drug labelling.

iv

Graseby 3300

PCA Pump

Contents

Graseby 3300

Page 1.

Introduction ... 2

2.

Product description ... 3

3.

Preparation for Infusion ... 4

4.

Switching on ... 5

5.

Loading the syringe ... 7

6.

Connecting the patient handset... 10

7.

Connecting a printer or personal computer ... 10

8.

Purging the infusion line ... 11

9.

Programming the pump ... 12

10.

Starting the pump ... 17

11.

Using the patient handset ... 19

12.

Reviewing the program settings ... 21

13.

Clinician override ... 21

14.

Stopping the pump ... 22

15.

Changing the syringe ... 23

16.

Patient History ... 24

17.

Printer ... 28

18.

Battery Operation ... 31

19.

Alarms ... 32

20.

Switching off ... 40

21.

Positioning the pump ... 40

22.

Configuration mode ... 40

23.

Setting the clock ... 44

24.

Standards ... 45

25.

Specifications ... 47

26.

Cleaning ... 49

27

Maintenance ... 49

28.

Performance Charts ... 50

1

PCA Pump

1.

Introduction

Thank you for choosing a Graseby 3300 PCA Pump. This Instruction Manual contains important information on operating and looking after your pump. So that you are completely familiar with all of the pump’s features please take the time to read this manual before switching the pump on. It is important that all users of the pump have been trained in how to use the pump. The Graseby 3300 PCA Pump is a bedside syringe pump, to which is connected a handset. Patient controlled analgesia (PCA) offers a proven, effective and superior alternative to the traditional methods of management for moderate to severe pain. The patient is able to communicate his requirement for analgesia via this handset. When the handset button is pressed, the pump delivers a fixed bolus of drug. Immediately after this a ‘lock-out’ period commences. During this lock-out period, the pump will ignore any further requests for analgesia. This is a safety feature designed to allow the drug to exert its maximum effect and prevent an overdose. Both the bolus size and lock out period are programmed into the PCA pump by the doctor and are determined by the pharmacokinetics and pharmacodynamics of the chosen analgesic. As a further option, the pump can be set to give a continuous infusion of drug which is independent of any patient requests for analgesia. This too is programmed in by the doctor. Access to the PCA pump program settings and the syringe can only be gained by inserting a special key into the IV pole clamp attached to the rear of the pump. This key might be kept with the keys to the controlled drugs cupboard.

2

Graseby 3300

PCA Pump

2.

Product Description

Alarm and alarm LED Syringe cover

Syringe barrel clamp

Display

Syringe cover lever

Syringe size sensor

Syringe ear groove

Plunger clamp Patient history key

Syringe cover pivot

Syringe cover pivot

Syringe size indicator LED's

Program change Purge key keys

AC Mains LED GM0752-B

Start and Program Start LED Power ON enter key

Power OFF RECHARGE

Stop and stop LED

Diagram 1 Front of Pump

Syringe cover spring

AC mains socket

Pole clamp grip

Lock and key

Patient handset Printer/monitor socket socket

GM0753-A

Diagram 2 Rear of Pump

Graseby 3300

3

PCA Pump

3.

Preparation for Infusion

Use only 20, 30 or 50/60ml syringes. The syringe must be sterile and for single use only. To minimise the effect of any syringe stiction, it is recommended that the smallest practicable syringe is used and that very low flow rates are avoided. Fill and prime the syringe and IV tubing in the normal way, ensuring that all air is expelled (page 11, purging, refers). Graseby Medical do not recommend combining PCA with other infusions through the same IV tubing without using a Y-connector with a non-return valve (Part No. 0128-0121, see diagram 3).

Connect to 3300 PCA Pump

Primary Infusion

Non return valve

To Patient GM0754-A

Diagram 3 It is recommended that as a safety precaution, an anti-siphon valve is used in the line from the syringe. WARNING: The volume of fluid contained in the connecting tubing is a residual amount and will not be infused. Hence this extra volume of fluid must be allowed for when initially filling the syringe and purging the system. Underdelivery of medication can cause complications resulting in patient injury or death.

4

Graseby 3300

PCA Pump

4.

Switching On

4.1 Operational keys The actions that take place when the various keys on the pump are pressed are listed below. Any active key pressed will be accompanied by a short beep, unless disabled from within the Configuration mode.

Operational buttons/keys and action performed Button

Action

ON

Power on.

OFF/RECHARGE

Power off (unless infusing). lf the AC power is connected then the internal batteries will be on charge.

START

Starts an infusion. Also used to confirm diagnostics/configuration/set date & time modes.

STOP

Stops the infusion. Silences the alarm.

Graseby 3300

PURGE

Used for purging the Infusion Line.

Patient History

Used for displaying the Patient History Totals

Key

Action

▲ ▼

Viewing Options (scrolling).

ENTER

Selecting options displayed.

5

PCA Pump 4.2

AC Supply Check that the label on the underside of the pump shows the voltage of the supply to which the pump will be connected. Connect to AC power. For battery operation refer to Section 18. Insert the AC power lead into the rear of the pump. Secure the mains lead with the clamp as shown in Diagram 4, this will prevent the lead from being accidently pulled out of the pump.

Diagram 4 The Mains Lead Clamp The AC Indicator lamp will illuminate. Press the ON key to switch on the pump. A brief self-test procedure will then be performed, during which a bleep will be heard. If the cover is open the pump will now be in ‘set-up’ mode, ready for programming. In the unlikely event of a fault being detected during the self-test procedure a continuous audible alarm will sound and a fault code will be displayed. WARNING: Do not use a faulty pump. If the pump develops a fault then an alarm will sound; the display will indicate a FAULT condition and the pump will fail to infuse. Incorrect performance of the pump can cause complications resulting in patient injury or death. If the pump develops a fault then it must be referred to a suitably qualified engineer or returned to Graseby Medical in order to have the fault rectified. WARNING: Failure to use the mains lead retainer means that the pump may be accidentally or erroneously disconnected from the mains. Although there is battery backup in case this happens, the battery may not be sufficiently charged. Consequently there is a risk of the pump not functioning, which could lead to patient injury or death.

6

Graseby 3300

PCA Pump

5.

Loading the Syringe

5.1

Syringe Brand Only use luer-lock syringes. When the pump is switched on the display will briefly indicate which brand of syringe the pump is Configured. A qualified technician can Configure the pump to accept any of the following syringe brands and sizes: WARNING: Use only the syringes and administration sets listed in the Specification at the end of this manual. Failure to do so may result in an inaccurate delivery. Graseby Medical does not guarantee performance of the pump if syringes other than those listed are used. Incorrect function or performance of the pump can cause complications resulting in patient injury or death.

Syringe brand Syringe sizes acceptable BD Plastipak 20ml, 30ml, 50/60ml. Braun Omnifix 20ml, 30ml, 50/60ml. Braun Perfusor 50ml (optional, requires conversion kit). Fresenius 50ml. DBL 50 50ml prefilled syringe. Monoject 20ml, 50/60ml. Terumo 20ml, 30/35ml, 50/60ml. If a syringe size smaller than 50/60 ml is going to be used for an infusion the following WARNING must be observed. WARNING: When using a syringe smaller than 50/60 the occlusion pressure will increase as the diameter of the syringe decreases, i.e. the smaller the syringe the higher the pressure.

5.2

Graseby 3300

Prime Syringe Fill and prime the syringe and catheter in the normal way (ensuring that all the air is expelled) in preparation for loading onto the pump.

7

PCA Pump 5.3

Insert Syringe If the pump is locked, insert the key into the pole clamp lock on the rear of the pump. Turn it through 90°. Push the syringe cover lever backwards and then draw the syringe cover forward. Swing the pump’s plunger clamp away from the body of the pump, until it clicks. Slide the plunger clamp fully to the right. Pull the syringe barrel clamp upwards and insert the primed syringe into the syringe trough. Ensure at the same time that the ear of the syringe is located in the groove and pushed fully to the left. The syringe size sensor should rest on the syringe barrel. Lower the syringe barrel clamp onto the syringe. Slide the plunger clamp to the left until it is touching the plunger. Swing the clamp towards the body of the pump until it clicks over the syringe plunger. Ensure the plunger cross piece is correctly placed within the plunger clamp.

WARNING: To avoid over- or under- infusion, always verify that the brand and size of the loaded syringe are the same as the brand and size displayed on the screen before starting an infusion. Failure to do so may result in an inaccurate delivery of medication, resulting in patient injury or death. WARNING: To avoid syphoning of the syringe contents (free flow), ensure that the syringe is correctly loaded into the pump, that the syringe plunger is properly engaged by the pump’s actuator and that the pump is placed not more than 80cm above the infusion site. Syphoning can result in over-infusion leading to patient injury or death.

8

Graseby 3300

PCA Pump Check: Syringe cover open

Check: Plunger clamp is flush with syringe plunger then lower over plunger

Check: Syringe size sensor is located on top of syringe

Check: Barrel clamp is located on top of syringe

GM0755-A

Diagram 5 Inserting the Syringe The syringes are disposable types for single use only. WARNING: Use only the syringes and administration sets listed in the Specification at the end of this manual. Failure to do so may result in an inaccurate delivery. Graseby Medical does not guarantee performance of the pump if syringes other than those listed are used. Incorrect function or performance of the pump can cause complications resulting in patient injury or death.

Graseby 3300

9

PCA Pump

6.

Connecting the Patient Handset

Push patient handset tubing firmly into the socket, as shown.

GM0756-A

Push handset tubing firmly into place

Diagram 6

7.

Connecting to a Printer or Computer

Push the cable firmly into the socket, as shown in diagram 7 and tighten the retaining screws (if fitted). It is recommended that a cable with retaining screws be used.

GM0757-A

Push connecting cable firmly into socket

Diagram 7 10

Graseby 3300

PCA Pump

8.

Purging the Infusion Line

The PURGE key is only operative when the syringe cover is open and the pump is in the program set-up mode, i.e.

! OR " TO ADJUST appears in the display

WARNING: To avoid patient embolism, ensure that the patient tubing is purged of all air bubbles before administering any medication. The pump provides a purge facility to assist with this process. The presence of air within the medication can result in complications leading to patient injury or death. WARNING: To avoid over-infusion, do not purge the infusion line when the administration set is connected to the patient. Over-infusion of medication can result in patient injury or death.

For safety reasons the purge facility cannot be used whilst the pump is infusing. Press the PURGE key, the display will show the message “PRESS AGAIN”. Press the PURGE key immediately and HOLD IT depressed. Whilst running in the purge mode the alarm lamp and run lamp will flash and the display will show the total fluid quantity delivered since the purge button was pressed. Maximum purge volume is 2ml for all syringe sizes.

Graseby 3300

11

PCA Pump

9. Programming the Pump

9.1

Programming the pump can only be carried out when the cover is open, and must only be undertaken by trained personnel. They must be conversant with each of the following: • an understanding of the principals of patient controlled analgesia, • an understanding of the meaning of each program step, • an appreciation of the significance of a selected program value. WARNING: To avoid incorrect or inappropriate configuration of the pump, the Configuration menu must only be selected by qualified persons or authorised personnel. Incorrect pump configuration could lead to inappropriate infusion resulting in patient injury or death.

9.2

Programming of the pump is ‘menu driven’. The display shows a program step, its current value and an invitation to adjust this value, using the ▲ and ▼ keys. Pressing ENTER stores the selected value and the display advances to the next program step. At the end of the program sequence the operator is invited to commence PCA. All program step values (except the loading dose) are remembered by the pump when it is switched off.

9.3

12

A unique feature of the 3300 PCA pump is its flexible optional program. This allows the operator to select (via the Configuration mode, Section 22) which program steps appear on the display during programming. The pump is despatched from the factory with the following program step sequence Configured: • DRUG CONCENTRATION. • LOADING DOSE. • PCA (BOLUS) DOSE. • DOSE DURATION. • LOCKOUT PERIOD. • CONTINUOUS INFUSION. • TOTALS SINCE RESET. In addition, the operator can add in any or all of the following program steps: • PATIENT ACTIVATED TIMED INFUSION. • TOTAL DOSE LIMIT (MASS UNITS & TIME). • TOTAL DOSE LIMIT (TIME PERIOD). Graseby 3300

PCA Pump 9.4

9.5

All program steps are listed below in the order in which they appear, together with an explanation of each step and its range of settings.

DRUG CONCENTRATION 1.00mg/ml Press ENTER

! OR " TO ADJUST This is the concentration of the drug in the syringe, expressed in MASS/VOLUME. It can be set in the range 1µg/ml to 99.5mg/ml. OPTIONAL 9.6

LOADING DOSE 0.0µg (0.0ml) Press ENTER

! OR " TO ADJUST This is the initial dose of drug given to the patient. It is administered immediately the syringe cover is closed and locked and the START key is pressed. It is expressed in MASS units and can be set in the range 0µg to 99.5mg. (The volume equivalent is also displayed and this depends on other settings). For safety reasons it always resets to zero after an infusion has been started. 9.7

The loading dose is always delivered at the STAT rate (see page 47).

PCA (BOLUS) DOSE 1.00mg (1.0ml) Press ENTER

! OR " TO ADJUST This is the amount of drug that will be infused following a successful demand from the patient. It too is expressed in MASS units and can be set in the range 0µg to 99.5mg. (The volume equivalent is also displayed and this depends on other settings). Graseby 3300

13